1. Field of the Invention
The present invention relates generally to medical apparatus and methods. More particularly, the present application relates to apparatus, systems, and methods for airway management using a tracheostomy tube. The invention also relates to a transcutaneous access device useful for placing a tracheostomy device or other medical apparatus.
A tracheostomy is a surgical procedure to form an opening into a patient's trachea (windpipe) to provide a temporary or permanent path for ventilation. Usually, a tube is inserted through the opening to allow passage of air and optionally removal of secretions. Instead of breathing through the nose and the mouth, the patient will breath directly through the “tracheal tube.” Tracheostomies are often performed in the event of respiratory failure and/or upper airway blockage, and the tracheal tubes may be connected to mechanical ventilators when the patient is unable to breathe on his or her own.
Tracheal tubes may be simple tubes which are bent downward into the trachea to provide the lumen passageway for inhalation and exhalation. Often, however, the tracheal tube will have an inflatable cuff at its lower end in order to provide an airtight system for mechanical ventilation.
Of particular interest to the present invention, tracheal tubes with an inflatable cuff may collect body secretions and other materials from oral cavities, nasal cavities and/or gastro-intestinal reflux into the trachea, which may travel down the trachea from reaching the lungs. Often, these secretions and other materials collect or pool on top of the inflated cuff, thus requiring periodic removal. Even with the cuff inflated, due to movement of the tracheostomy tube and the collection of the materials on top, there could be slow and continuous of the secretions around the cuff. Whenever the cuff is deflated, the secretions remaining on top of the cuff will flow downward into the lung, leading to significant complications. For example, exposure of the lungs to such secretions can cause “aspiration pneumonia” and other pathological conditions, which can have serious consequences and which can prolong and complicate a hospitalization and or even lead to death.
In addition to collection of nasal and other secretions, presently designed tracheal tubes have a number of other shortcomings. For example, many tracheal tubes are difficult to introduce and deploy through penetrations made in the tracheal wall. It can be even more difficult to remove and exchange tracheal tubes for cleaning, repair, or other purposes. Additionally, the inflatable cuffs on at least most trach tubes will be positioned below the tracheal penetration which can be disadvantageous in several respects. The device can be accidentally dislodged when attaching or removing other respiratory devices to the trach tube. In addition, the forces caused by airway irritation may cause the expulsion or dislodgment of the trach tube. Since these patients are dependent on mechanical ventilation, expulsion and dislodgment of the trach tube can cause significant morbidity. Furthermore, by placement of the cuff below the access site, the fluid collected above the cuff balloon can expose the tissue on the access site. Since these secretions are often rich in enzymes, it can lead to break down of the exposed tissue at the access site by the amylase of saliva. The degeneration of the exposed tissue by these enzymes is a well documented in clinical journals and is one of the leading causes of continuous enlargement of the access site for patients with chronic need for trach tube.
For these reasons, it would be desirable to provide improved tracheal tube designs and methods for their deployment and use. It would be particularly useful to provide tracheal tubes which allow for efficient and continuous removal of secretions without the need for separately accessing the tracheal tubes or removing any components of the tracheal tubes. It would be further desirable if the tracheal tubes were designed to permit easy introduction and removal of the tracheal tubes, thus permitting removal and exchange of tracheal tubes with minimum trauma to the patient. To that end, it would be desirable to provide access devices for penetrating the tracheal wall and providing an access port for insertion, removal, and replacement of the tracheal tube, particularly where the access device could be useful for other percutaneous access protocols. It would be still further desirable if the tracheal tubes were able to be firmly anchored in place within the tracheal penetration while causing minimal trauma and irritation to the patient. It is still further desirable that, with the tracheal tube in place, the penetration through the tracheal wall will be effectively sealed to prevent fluid and food aspiration into the lungs. Still further, it would be desirable to provide a tracheal tube which would facilitate patient speech while the tracheal tube is in place. At least some of these objectives will be met by the inventions described herein below.
2. Description of the Background Art
U.S. Pat. No. 6,840,242 describes a tracheostomy aspiration suction tube for use with or without a tracheostomy cuff. Other tracheostomy tubes are described in U.S. Pat. Nos. 6,612,305; 6,575,944; 6,460,540; 5,957,978; 5,653,231; 5,392,775; 5,107,828; 5,056,515; 5,054,484; 4,979,505; 4,280,492; 4,278,081; and published U.S. application 2003/0037789. Certain endotracheal tubes are described in U.S. Pat. Nos. 6,843,250; 5,501,215; 5,311,864; 5,143,062; 5,067,497; 4,840,173; and 4,305,392.